Privately held Thai biotech company, Immunitor Corporation Co., Ltd, has submitted to the Thai FDA the application for Phase III clinical trial. The application is based on pending investigational R&D drug permit that was granted in 2000. The primary endpoint of the trial is aimed at confirming the beneficial property of V-1 Immunitor (V1) shown for AIDS-associated wasting. When approved, the study will be carried out by the clinical team of Dr Orapun Metadilogkul, the president of Occupational and Environmental Medicine Association of Thailand at Rajavithi General Hospital in Bangkok - the largest public hospital of the Ministry of Public Health.
Recently published retrospective, large-scale study in 650 AIDS patients demonstrated that V1 was safe, effective, and highly promising as an inexpensive therapy for the management of opportunistic infections and AIDS-associated decline in body mass. The probability value obtained in this study (P=0.00000000000000065) indicates that obtained results were non-random and highly significant statistically. These findings support the results of open label phase I study published two years ago and of placebo-controlled phase II study completed last year.
V-1 Immunitor is an orally available therapeutic AIDS vaccine, which has been licensed in Thailand and certain countries in Africa as a dietary supplement. The vaccine elicits mucosal immune response in the gut, which appears to result in reversal of weight loss in 76 per cent of AIDS patients. Several published clinical trials have shown that V1 is safer and cheaper than standard antiviral therapy.
The Phase III trial seeking licensure for AIDS-related wasting represents a "streamlining" of the company's approval strategy. Obtaining drug label for such an indication is a stepping stone for Immunitor's ongoing research program aimed at developing effective and safe vaccine for treatment and prevention of HIV."
Principal Investigator, Dr Aldar Bourinbaiar, the scientific director of the company, said, "Our results compare very favorably to any published results of treatment for this indication. The results we have seen are the best I've observed with this difficult-to-treat condition, which is associated with certain death. Currently available nutritional supplements or cocktail antiviral drugs known as HAART are inefficient for correction of wasting and V1 can be useful add-on option to HAART or as stand-alone therapy. Other treatment options like recombinant human growth hormone (HGH), produced by Swiss company Serono, are quite effective but they are too expensive for third world countries."
Vichai Jirathitikal, the chairman of the Immunitor, said, "We plan to initiate a similar Phase III multi-site trial program in four countries in Africa. Depending on ethics committees' decision in respective countries the trials will start sometime before International AIDS Conference to be held in July of this year in Bangkok. We are especially proud that our charitable work which provided free treatment to more than 40,000 AIDS patients in Thailand and other developing countries led to the nomination of the Company for 2004 Bill Gates Award in Global Health."